CytoSorbents REFRESH 2-AKI Protocol Amendment Approved by FDA

MONMOUTH JUNCTION, N.J., Sept. 4, 2018 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO) a critical care immunotherapy leader using its CytoSorb® blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, announced that the REFRESH 2-AKI trial protocol amendment that was discussed in the August 2, 2018 earnings press release, has now been approved by the U.S. Food and Drug Administration (FDA). As previously discussed, based on the recommendations of key clinical advisors, a protocol amendment was submitted to the FDA to improve operational aspects of the patient screening process and expand the inclusion criteria. These changes were back-tested against patient screening logs and were designed to facilitate enrollment and broaden the applicable market for CytoSorb. The approved amendment has now been distributed to 9 active clinical trial sites, 7 additional sites nearing budget and contract finalization, and 9 additional sites completing start-up activities, awaiting individual ethics committee review.

Dr. Eric Mortensen, Chief Medical Officer of CytoSorbents Corporation stated, “We thank the FDA for their rapid review and approval of this protocol amendment. Following expected approval by the site ethics committees, we are targeting 15-20 active sites screening for patient enrollment into the REFRESH 2 – AKI trial in the next couple of months. Feedback from the clinical sites on the protocol revisions has been very positive and we expect enrollment to significantly increase.”

CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb® is approved in the European Union with distribution in 53 countries around the world, as an extracorporeal cytokine adsorber designed to reduce the “cytokine storm” or “cytokine release syndrome” that could otherwise cause massive inflammation, organ failure and death in common critical illnesses. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb® is also being used during and after cardiac surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. CytoSorbents recently initiated its pivotal REFRESH 2-AKI trial – a multi-center, randomized controlled, clinical trial intended to support U.S. regulatory approval of CytoSorb for use in a heart-lung machine during complex cardiac surgery to reduce organ injury. CytoSorb® has been used in more than 46,000 human treatments to date.

CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of approximately $25 million from DARPA, the U.S. Army, the U.S. Department of Health and Human Services, the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), U.S. Special Operations Command (USSOCOM), and others. The Company has numerous products under development based upon this unique patented blood purification technology including CytoSorb-XL™, HemoDefend™, VetResQ™, K+ontrol™, ContrastSorb, DrugSorb, and others. For more information, please visit the Company’s websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.

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